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J Hepatol. 2015 Sep;63(3):581-5. doi: 10.1016/j.jhep.2015.04.023. Epub 2015 May 1.

Sofosbuvir plus ribavirin for treating Egyptian patients with hepatitis C genotype 4.

Author information

1
National Hepatology and Tropical Medicine Research Institute, Cairo, Egypt.
2
Egyptian Liver Research Institute and Hospital (ELRIAH), Mansoura, Egypt. Electronic address: g_shiha@hotmail.com.
3
Egyptian Liver Research Institute and Hospital (ELRIAH), Mansoura, Egypt.
4
University of Cairo, Cairo, Egypt.
5
Gilead Sciences, Inc., Foster City, CA, United States.

Abstract

BACKGROUND & AIMS:

Egypt has the highest prevalence of chronic hepatitis C virus (HCV) infection in the world, and more than 90% of patients are infected with genotype 4 virus. We evaluated the efficacy and safety of the HCV polymerase inhibitor sofosbuvir in combination with ribavirin in HCV genotype 4 patients in Egypt.

METHODS:

Treatment-naïve or treatment-experienced patients with genotype 4 HCV infection (n=103) were randomly assigned to receive either 12 or 24 weeks of sofosbuvir 400 mg and ribavirin 1000-1200 mg daily. Randomization was stratified by prior treatment experience and by presence or absence of cirrhosis. The primary endpoint was the percentage of patients with HCV RNA <25 IU/ml 12 weeks after therapy (SVR12).

RESULTS:

Among all patients, 52% had received prior HCV treatment and 17% had cirrhosis at baseline. SVR12 rates were 90% (46/51) with 24 weeks and 77% (40/52) with 12 weeks of sofosbuvir and ribavirin therapy. Patients with cirrhosis at baseline had lower rates of SVR12 (63% 12 weeks, 78% 24 weeks) than those without cirrhosis (80% 12 weeks, 93% 24 weeks). The most common adverse events were fatigue, headache, insomnia, and anemia. Two patients experienced serious adverse events (cerebral ischemia, dyspnea). No adverse events resulted in treatment discontinuation.

CONCLUSION:

Sofosbuvir plus ribavirin for 12 or 24 weeks is effective in treating both treatment-naïve and treatment-experienced Egyptian patients with genotype 4 HCV.

KEYWORDS:

Antiviral agents; Egypt; Genotype 4; Hepatitis C; Polymerase inhibitor; Sofosbuvir

PMID:
25937436
DOI:
10.1016/j.jhep.2015.04.023
[Indexed for MEDLINE]

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